Administrative Law

Major Medical Institutions Allegedly Failing to Report Clinical Trials

December 16, 2015
Administrative Law, Food and Drug Law

Jessica Jayasuriya, MJLST Managing Editor

The Food and Drug Administration Amendments Act of 2007 requires that parties responsible for clinical trials submit clinical trial inform to the Director of NIH no later than one year after either the end date or the estimated end date of the trial.

However, several sources are alleging that Stanford University, Memorial Sloan Kettering Cancer Center, the University of Pennsylvania, the University of Pittsburgh, the University of California San Diego, and other major medical research institutions are failing to submit their clinical trial results within the deadline, and sometimes even at all.

The public database created by the legislation was intended to help the public, particularly medical professionals, scientists, and other researchers, to quickly access the latest findings on human testing of drugs, medical devices, and the like.

Institutions’ failure to turn in their results, however, is directly counteracting this legislative purpose. This is particularly concerning because doctors may not be getting critical information including adverse events in drug trials.

Interviews with the offending institutions indicate that the primary reason for these deadline lapses on the institutions’ end is due to being too busy and a lack of funding. Memorial Sloan Kettering, however, specifically stating it submitted some of its reporting in order to finish medical journal articles related to its trials. On top of institution failures to submit, is clear that the NIH is compounding the issue by failing to follow up on clinical trial deadlines.

Experts interviewed by the sources have further expressed concern that pressure from sponsoring drug companies may also be part of the reason why these clinical trials are not coming to light.

Circumventing EPA Regulations Through Computer Programs

December 16, 2015
Administrative Law, Data, Environmental Law

Ted Harrington, MJLST Staffer

In September of 2015, it was Volkswagen Group (VW). This December, it was the General Electric Company (GE) finalizing a settlement in the United States District Court in Albany. The use of computer programs or other technology to override, or “cheat,” some type of Environmental Protection Agency (EPA) regulation has become seemingly commonplace.

GE uses silicone as part of its manufacturing process, which results in volatile organic compounds and chlorinated hydrocarbons, both hazardous byproducts. The disposal of hazardous materials is closely regulated by the Resource Conservation and Recovery Act (RCRA). Under this act, the EPA has delegated permitting authority to the New York State Department of Environmental Conservation (DEC). This permitting authority allows the DEC to grant permits for the disposal of hazardous wastes in the form of an NYS Part 373 Permit.

The permit allowed GE to store hazardous waste, operate a landfill, and use two incinerators on-site at its Waterford, NY plant. The permit was originally issued in 1989, and was renewed in 1999. The two incinerators included an “automatic waste feed cutoff system” designed to keep the GE facility in compliance with RCRA and the NYS Part 373 Permit. If the incinerator reached a certain limit, the cutoff system would simply stop feeding more waste.

Between September 2006 and February 2007, the cutoff system was overridden by computer technology, or manually by GE employees, on nearly 2,000 occasions. This resulted in hazardous waste being disposed of in amounts grossly above the limits of the issued permits. In early December, GE quickly settled the claim by paying $2.25 million in civil penalties.

Beyond the extra pollution caused by GE, a broader problem is emerging—in an increasingly technological world, what can be done to prevent companies from skirting regulations using savvy computer programs? With more opportunities than ever to get around regulation using technology, is it even feasible to monitor these companies? It is virtually certain that similar instances will continue to surface, and agencies such as the EPA must be on the forefront of developing preventative technology to slow this trend.

Just Not Mayo

December 2, 2015
Administrative Law, Agriculture, Competition, Food and Drug Law

Nolan Hudalla, MJSLT Staffer

In August 2015, the U.S. Food and Drug Administration (FDA) issued a warning letter to Hampton Creek Foods, the makers of the popular vegan mayonnaise substitute “Just Mayo.” This letter informed the company that its product had a misleading name and label imagery, because, by FDA regulation, mayonnaise must contain one or more eggs. This opinion by the FDA was in response to a high-profile lawsuit brought against Hampton Creek by Unilever (the makers of Hellmann’s Mayonnaise) and a similar class action filed in Florida state court, both alleging violation of the Florida Deceptive and Unfair Trade Practices Act and unjust enrichment. But, in an era of healthier alternatives – a world of Whole Foods, Thanksgiving Tofurky, and even eggless mayo – is the FDA missing the point? Instead of relying on food recipes enshrined in agency regulations from the 1970’s to identify whether an eggless substitute is mayonnaise or not, maybe the FDA needs to modernize its definitions instead.

In an effort to demonstrate just how committed the government is to keeping Just Mayo from poaching the traditional mayo market, consider the American Egg Board’s (AEB) response to Just Mayo. The AEB, a group appointed by the US Department of Agriculture, may have used public funds to conspire against Just Mayo. According to a Guardian article, “the government-backed egg lobby had organized a concerted effort to tackle Hampton Creek, a company described in leaked emails as a ‘major threat’ and ‘crisis’ for the $5.5bn-a-year egg industry.” This investigation led to the resignation of the AEB’s CEO Joanne Ivy. In addition, the FDA sent Just Mayo its warning letter despite an enormous show of popular support against the agency’s policy. Over 112,000 petitioners scrambled to sign a petition started by Food Network star Andrew Zimmern entitled “Stop Bullying Sustainable Food Companies,” to Unilever Chairman Michael Treschow. This public uprising boiled to the point that Unilever voluntarily dropped its initial lawsuit within two days of filing.

Even if the Florida state court suit amounts to nothing, this issue will not be over easy for the FDA. As demonstrated by the petition, consumer preferences are changing, and not just for mayonnaise. Similar battles are being fought over peanut butter, milk, yogurt, and ice cream. Retail sales of vegan products rose by over 6% last year, and 36% of U.S. consumers use milk or meat alternatives. This raises the question of whether it is really worth all of the government’s money and effort to maintain 1970’s ideas of food. Instead of deviling these modern alternatives, maybe the FDA should buy in too. After all, it’s just mayo.

Let’s Talk: The Cold & Flu Season & Personalized Medicine

November 13, 2015
Administrative Law, Food and Drug Law, Health Law, Public Health

Allison Kvien, MJLST Managing Editor

As we approach cold and flu season, it is time we all start thinking about properly taking care of ourselves. Many individual factors have been linked to your heath. A Newsweek article reported that people who get less than 5 hours of sleep a night are 4.5 times as likely to become ill. According to The L.A. Times, an elevated heart rate could mean that a cold is on the way. Finally, an article from Harvard found a link between your popularity and how early in the season you become ill (yes, really—and I guess this explains why I haven’t gotten the flu since I was a kid). While this is all helpful information, it represents only a few factors that contribute to a person’s overall health. Over the years, the practice of medicine has become more accepting of the concept that “one size does not fit all” and that patients may need more personalized medicine.

One interesting development in personalized medicine was ten years ago, in 2005, when FDA approved the first race-specific drug, BiDil. As Dorothy E. Roberts explained in her MJLST article, BiDil, is “a combination drug that relaxes the blood vessels, [and] was authorized to treat heart failure in self-identified black patients.” Many scholars and citizens alike have found the approval of BiDil controversial, for a variety of reasons, legal, political, ethical, and otherwise. It may be, however, simply one more step on the path to personalization of medicine for patients. As Roberts reported, “BiDil increased survival by an astonishing 43 percent. Hospitalizations were reduced by 39 percent.” Roberts’s opinion, however, was that BiDil should have been approved for all heart failure patients, regardless of race because there was no underlying genetic difference in African Americans that the drug relied on for its positive results. The economic results of the BiDil drug may prevent others from going developing race-specific drugs for a while, though; BiDil has been described as a “flop.”

Cold season medicine is normally pretty generic. Think: Airborne, Sudafed, Advil, and cough drops, my favorite of which are the less-than-pleasant tasting Fisherman’s Friends that completely numb your throat—seriously, try them. I think the concept of personalized cold and flu medicine is particularly interesting because our current cold season medicine is normally over-the-counter and generalized. Can you imagine a future where you pick up a cold medicine tailored specifically to your genetic background? Well, it may already be happening. Just two years ago, FDA approved personalized flu vaccines for three groups: the elderly, children, and those with allergies. These personalized vaccines may allow some groups of our population to receive them when they wouldn’t otherwise be able to, or to at least receive them more safely. Specifically for flu vaccines, anyway, this step in personalization may not also reflect increased overall effectiveness in preventing illness. But let’s not give you an excuse to not get your flu vaccine. Go get that flu shot that was made just for you!

Let’s Talk: The Cold & Flu Season & Personalized Medicine

November 13, 2015
Administrative Law, Food and Drug Law, Health Law, Public Health

Allison Kvien, MJLST Managing Editor

As we approach cold and flu season, it is time we all start thinking about properly taking care of ourselves. Many individual factors have been linked to your heath. A Newsweek article reported that people who get less than 5 hours of sleep a night are 4.5 times as likely to become ill. According to The L.A. Times, an elevated heart rate could mean that a cold is on the way. Finally, an article from Harvard found a link between your popularity and how early in the season you become ill (yes, really—and I guess this explains why I haven’t gotten the flu since I was a kid). While this is all helpful information, it represents only a few factors that contribute to a person’s overall health. Over the years, the practice of medicine has become more accepting of the concept that “one size does not fit all” and that patients may need more personalized medicine.

One interesting development in personalized medicine was ten years ago, in 2005, when FDA approved the first race-specific drug, BiDil. As Dorothy E. Roberts explained in her MJLST article, BiDil, is “a combination drug that relaxes the blood vessels, [and] was authorized to treat heart failure in self-identified black patients.” Many scholars and citizens alike have found the approval of BiDil controversial, for a variety of reasons, legal, political, ethical, and otherwise. It may be, however, simply one more step on the path to personalization of medicine for patients. As Roberts reported, “BiDil increased survival by an astonishing 43 percent. Hospitalizations were reduced by 39 percent.” Roberts’s opinion, however, was that BiDil should have been approved for all heart failure patients, regardless of race because there was no underlying genetic difference in African Americans that the drug relied on for its positive results. The economic results of the BiDil drug may prevent others from going developing race-specific drugs for a while, though; BiDil has been described as a “flop.”

Cold season medicine is normally pretty generic. Think: Airborne, Sudafed, Advil, and cough drops, my favorite of which are the less-than-pleasant tasting Fisherman’s Friends that completely numb your throat—seriously, try them. I think the concept of personalized cold and flu medicine is particularly interesting because our current cold season medicine is normally over-the-counter and generalized. Can you imagine a future where you pick up a cold medicine tailored specifically to your genetic background? Well, it may already be happening. Just two years ago, FDA approved personalized flu vaccines for three groups: the elderly, children, and those with allergies. These personalized vaccines may allow some groups of our population to receive them when they wouldn’t otherwise be able to, or to at least receive them more safely. Specifically for flu vaccines, anyway, this step in personalization may not also reflect increased overall effectiveness in preventing illness. But let’s not give you an excuse to not get your flu vaccine. Go get that flu shot that was made just for you!

EPA Revises Agricultural Worker Protection Standard, to the Disappointment of Agriculture Industry Groups

November 13, 2015
Administrative Law, Environmental Law

Jody Ferris, MJLST Staffer

An important development on the regulatory front has some agriculture industry groups shaking their heads. The U.S. Environmental Protection Agency has released finalized revisions to the 1992 Agricultural Worker Protection Standard on Sept. 28, 2015 (40 CFR 170). These regulations apply to millions of agricultural workers in fields, forests, orchards, and greenhouses across the country. The regulations are meant to enforce the observation of good safety practices in the use of pesticides by agricultural workers.

The changes to the current requirements include:

-a new minimum age requirement that prohibits children under the age of 18 from handling pesticides.

-mandatory posting of no-entry signs on fields that have been recently treated with highly dangerous pesticides.

-whistleblower protections to protect employees who alert authorities to illegal practices.

-increased frequency of employer provided safety training (now required annually, up from the previous requirement of every five years).

-recordkeeping requirements (records of training must be kept for two years, previous requirements did not require any record keeping).

-increased requirements for use of safety equipment, including fit testing and employee training on use of safety equipment. Recordkeeping of completion of safety equipment training and fit testing is also required. The previous requirements did not require any training, formal fit testing, or record keeping.

Agricultural industry groups are unhappy with many of the revisions to the regulations. A coalition including the National Association of Wheat Growers, the National Council of Farmer Cooperatives, the American Farm Bureau Federation, and the American Seed Trade Association submitted a 14-page comment letter during the public comment period and claim that their comments were not taken under proper consideration in the final revision of the rule. The coalition argued that since the original regulations were introduced in 1992, there have been significant improvements in worker safety and that acute poisoning events have been greatly reduced, thereby eliminating the need for more stringent regulations. In addition, they argue that the EPA has severely underestimated the financial costs that the new requirements place on agricultural producers. Criticism from the Agricultural Retailers Association includes the concern that the new rules will put employers at risk for increased liability without significantly increasing worker safety.

It is currently unclear whether any regulated parties will seek to challenge the revised regulations in court. It also remains unclear precisely how great a burden the new requirements will place on agricultural producers or how much they will improve the safety of workers until they are followed in practice for some time. It remains to be hoped that the new requirements will indeed significantly improve the safety of agricultural workers on the job and justify any increased burden on employers.

H.R.8 and the Hydropower Improvement Act of 2015—Another Missed Opportunity

October 28, 2015
Administrative Law, Energy Law, Environmental Law

Catherine Cumming, MJLST Lead Note & Comment Editor

While many people see the hydropower industry as a clean and sustainable energy source, most hydropower facilities are decades old and have severe environmental, economic, and social externalities. Relicensing provides an opportunity to bring aging dams up to modern environmental standards and compliance requirements. Over the past thirty years, American Rivers and the Hydropower Reform Coalition used the licensing process to improve hydropower dams and restore rivers. With over 6,000 megawatts of hydropower due for relicensing within the next five years, there are hundreds of dams and thousands of miles of river with an opportunity for improvement. Recent legislation, however, has failed to address the amount of hydropower due for relicensing and the opportunities it presents for increased energy production and environmental compliance. When Congress passed the Hydropower Regulatory Efficiency Act of 2013, it failed favored efficiency over oversight and failed to the amount of hydropower due for relicensing and the opportunity it provided for efficiency upgrades.

This fall, Congress missed yet another opportunity to modernize hydropower and decrease its negative externalities. Rather than “modernize” hydropower, the Energy & Commerce Committee’s approval of a hydropower amendment to H.R.8, the “North American Energy Security and Infrastructure Act of 2015” and Senator Lisa Murkowski’s “Hydropower Improvement Act” ignore the opportunity for increased efficiency and sustainability by creating compliance loopholes for the hydropower industry. If enacted, these bills would allow energy companies to opt out of Clean Water Act, Endangered Species Act, and state water quality and wildlife protections; allow dam owners to pass the costs and burdens of obeying water quality standards, wildlife laws, and cleaning up pollution caused by dams to taxpayers; and transfer state and federal agency authority to protect natural resources to the Federal Energy Regulatory Commission. While 2011 was the “Year of the River,” 2015 is becoming the “Year of Hydropower.” Community interest groups and environmental organizations are concerned that H.R.8 and the “Hydropower Improvement Act” will “turn back the clock and take the hydropower industry back to a time when they could destroy rivers with impunity.”

Shape Up or Ship Out: E.P.A. Forced to Reevaluate Their General Ballast Water Regulation Permit

October 20, 2015
Administrative Law, Environmental Law

John Biglow, MJLST Staffer

In the recently decided Natural Resources Defense Council v. U.S. E.P.A., — F.3d — (2d Cir. Oct. 5, 2015), the Second Circuit granted the petitioners’ motion, in part, for a review of the Environmental Protection Agency’s 2013 Vessel General Permit (VGP) regulating the discharge of ballast water from ships. The petitioners, four environmental conservation organizations, argued successfully that the EPA acted arbitrarily and capriciously in a number of ways when it set the technology based effluent limits (TBELs) and water quality-based effluent limits (WQBELs) which must be complied with under its VGP. In so deciding, the Second Circuit has remanded the matter to the EPA for proceedings consistent with their opinion, and has kept the 2013 VGP in place until the EPA issues a new VGP.

The EPA has the authority to regulate ballast discharge under §402(a) of the Clean Water Act (CWA). When freighter ships take on or unload cargo, they adjust for changes in weight by taking on or discharging ballast water. As the court stated, this amount “can range from hundreds of gallons to as much as 25 million gallons.” The regulation of ballast discharge is an important aspect of environmental conservation due to its role as a conduit for the spread of invasive species and pollutants. When a ship takes on ballast water in a polluted or infested area, it is possible for these organisms and pollutants to get sucked up with the water, surviving in the ballast tanks before being discharged in some distinct body of water. One study referenced by the court estimated the damage from invasive species to be upwards of $137 billion annually, making the prevention of their spread both a top environmental and economic priority.

The first set of arguments made by the petitioners centered on whether the TBELs set by the EPA were arbitrary and capricious. The petitioners first argued that in setting the TBEL standard to mirror the standard adopted by the International Maritime Organization in 2004 (the IMO standard), the EPA acted arbitrarily and capriciously. The Court agreed, primarily because a higher standard was attainable. The CWA requires the EPA to apply the “best available technology economically achievable” (BAT) when setting their TBELs. In its investigation of the available technology, the EPA employed the Science Advisory Board (SAB) to issue a report on the different available systems. According to their report, there were a number of ballast-water treatment systems that would be able to achieve standards 10 to 100 times greater than the IMO in the near future. By ignoring this potential and instead setting the standard at the IMO, the court found that the EPA acted arbitrarily and capriciously.

Next, the petitioners argued that the EPA acted arbitrarily and capriciously when it limited the SAB’s investigation of ballast treatment systems to shipboard treatment; ignoring onshore treatment options. The court agreed, refusing arguments from the EPA that these systems were not considered because the facilities needed to implement them were not yet in existence. The court reasoned that the time and expense of creating onshore treatment infrastructure was similar to that required for shipboard treatment, and that it was arbitrary and capricious to ignore the possibility. In remanding this issue back to the EPA, the agency will need to fully consider onshore treatment options before adopting or dismissing them in their new VGP.

The petitioners further argued that the EPA was arbitrary and capricious in exempting ships built before 2009 that only sail the great lakes water system (pre-2009 Lakers). The court agreed, reasoning that there was no true distinction between pre- and post-2009 Lakers. The court further stated that exempting ships because they did not currently have the technological capacity to adopt the technology necessary to meet the VGP requirements conflicted with the CWA’s BAT requirement, which seeks to force technology to keep up with contemporary environmental demands.

The petitioners next argued that several facets of the WQBELs were arbitrary and capricious. The WQBELs were designed as a safeguard to be utilized when the TBELs alone are insufficient to meet and maintain water quality standards. In its 2013 VGP, the EPA refused to set numerical values for its WQBELs, instead stating simply that “Your discharge must be controlled as necessary to meet applicable water quality standards in the receiving water body or another water body impacted by your discharges.” The court agreed that setting a narrative WQBEL was arbitrary and capricious, noting that it fails to give ship owners clear guidance as to whether or not they are in compliance with the WQBELs.

The petitioners also argued that the monitoring requirements of the WQBELs was arbitrary and capricious. The 2013 VGP required only that ship owners monitor the expected time, place, and volume of their ballast discharges. The court agreed, reasoning that the EPA could consider requiring ship owners to monitor the actual statistics on their ballast discharges, rather than the expected ones.

It is a critical victory for environmentalists that the Second Circuit is requiring the EPA to revisit what was an incomplete and insufficient 2013 VGP; however, it is critical that the EPA get it right the second time around. The economic and environmental impact of ballast discharges is significant and due to the cost and time requirements involved in creating the infrastructure necessary to meet the VGP system requirements, we are likely to be stuck with whatever the EPA sets as the BAT for a very long time.

Awaiting an Important Decision on the Gulf of New Mexico “Dead Zone” Lawsuit

September 5, 2015
Administrative Law, Environmental Law

Allison Kvien, MJLST Managing Editor

In 2013, the U.S. Environmental Protection Agency was ordered to set limits on nitrogen and phosphorous levels in U.S. waterways. These nutrients contribute to the loss of oxygen and cause what is called hypoxia to occur in the water, killing marine life. This year, the “dead zone” in the Gulf is larger than Connecticut and Rhode Island combined. While this is larger than average, it is not a record. The oxygen levels are so low in this zone that it was reported that even starfish are suffocating.

An appeals court recently decided that the district court should determine, based on the Clean Water Act (CWA), whether the EPA gave adequate reasons for its refusal to set limits on the nutrients in U.S. waterways. Environmental groups, such as the NRDC, are optimistic that the original ruling requiring the EPA to set nutrient limits will be reaffirmed by the district court.

This CWA ruling is analogous to the 2007 Supreme Court Clean Air Act (CAA) case, Massachusetts v. EPA, which ruled that the EPA must have good reasons, based on the CAA, for refusing to regulate greenhouse gases (GHGs). The Supreme Court found that the EPA’s rationale for not regulating GHGs was inadequate and required the EPA to come back with a reasonable basis for not regulating GHGs in order to avoid being forced to regulate GHGs.

If the outcome of this CWA lawsuit is that the EPA is required to regulate nutrients causing the enormous hypoxia zone, the EPA will embark on a hugely collaborative journey to set appropriate limits for these nutrients all over the country. For instance, the NRDC reports that Chicago, over one thousand miles away from the Gulf, was found to be the single largest contributor to the “dead zone” in the Gulf.

USDA Heightened Country of Origin Labelling Laws: Good Start, Can Be Tightened

April 25, 2015
Administrative Law, Agriculture, Food and Drug Law

Vinita Banthia, MJLST Staff Member

The Country of Origin Labeling (COOL) laws have long been debated and amended in the Unites States. COOL regulation dictates the degree to which a product’s label must indicate which countries were involved in the production of the product. Currently, a product’s countries of origin must be labelled for the all of its ingredients, with the exception of where the product has been processed. These standards apply to food such as meat that had been born and raised in the United States but contains elements that have been produced in other countries like China. Hence, all raw foods and its ingredients must be labelled, including “raw muscle cuts, ground commingled meat, or live imported animals are not excluded.”

However, if meat has been born and raised in the United States, and then shipped to China for processing, then shipped back to the United States for consumption, it does not need to be labelled as being processed in China. Except for locations of processing, meat must be labelled for the countries where the animal lived during its life, and where it was subsequently “raised, slaughtered, butchered, and prepared for sale.” These laws have become increasingly strict since changes in the U.S. Department of Agriculture (USDA) consumer information policies in 2009 and 2013.

The recent Note, Country of Origin Labeling Revisited: Processed Chicken from China and the USDA Processed Foods Exception published in the Minnesota Journal of Law, Science, and Technology, by Daniel Schueppert highlights the stringent COOL requirements for raw and live foods. The Note discusses the recent change in the USDA funding and regulation policies that allowed the United States to export chicken to China for processing, and then import it back in to the US for commercialization without labelling the meat’s journey. The agricultural industry and grocery stores have been largely opposed to the laws as requiring excessive labelling for non-processed meats. Canada and Mexico have challenged the U.S. COOL laws at the WTO, stating that the COOL requirements for non-processed meat are overly burdensome on Canadian and Mexican beef exporters, thereby creating an unfair advantage for U.S. domestic beef. In October 2014, the WTO ruled in favor of Canada and Mexico. Canada has threatened retaliatory actions if the U.S. does not relax its COOL laws.

In contrast, Schueppert argues that some, limited COOL standards should also be applied to meat processed in China. This position supports greater restrictions not only for non-processed and raw foods, but also for processed meats. In addition, Schueppert argues that the current definition of processed foods is too broad and over-inclusive, leading to potential safety concerns in non-processed products. This argument holds more ground that the views of industries and countries unwilling to invest greater resources in ensuring the safety and disclosure of products. The USDA should continue to take measures to ensure that meat products are increasingly safe and well-labelled for consumers.

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